Ursodeoxycholic acid Bulk Supply for Industrial Use
China Factory Direct
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| CAS number | 128-13-2 |
| Product name | Ursodeoxycholic acid |
| Stock | Stock readily available; annual supply capacity exceeding 1,000 tons. |
| Grade | Pharmaceutical GradeReagent GradeFood GradeCosmetic Grade |
| Packaging | 25KG/bag500KG/bag1000KG/bag |
| Sample | Test Samples Available (Click to Request Samples) |
| COA | View COA |
| Price | Get Quote |
| Supply Type | Bulk / Contract manufacturing / OEM |
| Shipping | FCL / LCL available |
| Payment Terms | Support FOB \ CIF \ EXW quotations, and accept Letter of Credit (L/C). |
| Manufacturer | Greenrock Chemical(China Factory) |
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Documents We Provide for Ursodeoxycholic acid
Post-sale: Full documentation is provided.
To request documents, please contact us via email at sales@GRchemical.com.
Bulk Ursodeoxycholic acid Supplier from China
17+ years in chemical exports.Fully compliant, reliable supply.Your B2B partner in bulk chemical procurement.
Industrial Applications of Ursodeoxycholic acid
| Industry | Application | Process |
|---|---|---|
| Pharmaceuticals | Dissolution of cholesterol gallstones | Used in the treatment of cholesterol gallstones by inhibiting cholesterol synthesis and secretion in the liver |
| Pharmaceuticals | Treatment of primary biliary cholangitis | Administered as a first-line therapy to improve bile flow and mitigate hepatic injury |
| Pharmaceuticals | Pediatric cholestatic disorders | Applied in the treatment of certain pediatric liver diseases, such as progressive familial intrahepatic cholestasis |
| Pharmaceutical Manufacturing | Intermediate in drug synthesis | Serves as a starting material for synthesizing other bile acid derivatives or related pharmaceuticals |
| Laboratory Research | Biochemical reagent | Employed in studies of bile acid metabolism, liver function, and apoptosis mechanisms |
| Food/Dietary Supplements | Hepatoprotective functional ingredient | Incorporated into select dietary supplements to support liver health |
| Cosmetics | Skin-conditioning agent | Used at low concentrations in certain skincare products for its potential anti-inflammatory and skin-repair properties |
Manufacturing Quality Control of Ursodeoxycholic acid
| Detection Item | Common Testing Methods | Method Overview |
|---|---|---|
| Content Determination | High-Performance Liquid Chromatography (HPLC) | Reverse-phase HPLC (RP-HPLC) is employed using a C18 column as the stationary phase. The mobile phase typically consists of methanol-water or acetonitrile-phosphate buffer, with detection wavelengths set at 205–220 nm. This method offers strong specificity and high sensitivity, making it the most widely used technique for content determination. |
| Purity Check | High-Performance Liquid Chromatography (HPLC) | Impurities are quantitatively analyzed using either the self-reference method or external standard method. This approach effectively detects both known and unknown impurities, enabling assessment of product purity in compliance with pharmacopeial standards (e.g., Chinese Pharmacopoeia, USP). |
| Impurity Analysis | Liquid Chromatography-Mass Spectrometry (LC-MS) | Combines liquid chromatographic separation with mass spectrometric detection to enable accurate qualitative and quantitative analysis of structurally similar impurities (e.g., chenodeoxycholic acid, cholic acid), particularly suitable for trace-level impurities and metabolites. |
| Polymorphic Analysis | X-Ray Diffraction (XRD) | Determines crystal structure characteristic peaks to identify the polymorphic form of ursodeoxycholic acid (e.g., α-form or β-form), which is critical for product quality, stability, and dissolution behavior. |
| Melting Point Determination | Microscopic Melting Point Method or Differential Scanning Calorimetry (DSC) | Used to confirm physical properties in accordance with standards. The typical melting point of ursodeoxycholic acid ranges from 200–205°C, serving as a preliminary identification and purity evaluation tool. |
| Related Substances Testing | HPLC (Self-Reference Method of Main Component) | Separates and quantifies potential degradation products or synthetic by-products under specific conditions to ensure total impurity levels remain within acceptable limits specified by pharmacopeial guidelines. |
| Moisture Content Determination | Karl Fischer Titration | Accurately measures water content in samples. Given that ursodeoxycholic acid is prone to moisture absorption, controlling moisture is essential for formulation stability. |
| Residual Solvent Testing | Gas Chromatography (GC) | Uses headspace or direct injection methods to detect residual organic solvents (e.g., ethanol, acetone, dichloromethane) from manufacturing processes, complying with ICH Q3A/B guidelines. |
| UV-Visible Spectroscopy (UV-Vis) | UV-Vis Spectrophotometry | Used for preliminary identification and auxiliary content determination. Ursodeoxycholic acid exhibits a characteristic absorption peak between 230–240 nm, though its specificity is relatively low and it is generally used as a supporting method. |
Technical Specifications of Ursodeoxycholic acid
| Test Item | Specification |
|---|---|
| Appearance | White powder |
| Purity | >=98.0% |
| Water Content (KF) | <=0.5% |
| Melting Point | 200-204°C |
| Optical Rotation | +59.0 to +62.0 degrees (c=1, in methanol) |
| Total Impurities | <=2.0% |
| Single Impurity | <=0.5% |
| Heavy Metals | <=10 ppm |
| Residue on Ignition | <=0.1% |
| Identification (NMR) | Conforms to reference spectrum |
Specifications vary by industry. Reach out to our technical experts for a COA tailored specifically to your application. Email:selse@GRchemical.com
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Download COA of Ursodeoxycholic acid
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| Lot/Batch Number | *Required fields | |
NMR Spectra of Ursodeoxycholic acid
Packaging of Ursodeoxycholic acid
Industrial Ursodeoxycholic acid Procurement FAQ
1. How do you ensure product quality consistency?
We rely on a mature China-based manufacturing system and implement strict batch control and quality inspection for every shipment. Our production process complies with ISO 9001 standards, and a COA is provided for each batch to ensure consistent and reliable quality.
2. Do you offer competitive pricing for bulk orders?
Yes, as a China-based manufacturer and bulk supplier, we provide tiered pricing based on order volume. We support FOB and CIF quotations, as well as L/C payment terms for large transactions to meet international trade requirements.
3. Can you support large-volume or long-term supply?
We have stable production capacity and a well-established supply chain, enabling continuous bulk supply. We support ton-level and container-level orders, as well as long-term cooperation projects.
4. What is your typical lead time?
For in-stock products, shipment can be arranged within 1–3 days. For bulk packaging or customized orders, lead time depends on the specific quantity and production schedule.
5. What documents do you provide?
We can provide complete documentation upon request, including COA, SDS, TDS, and other compliance certificates, meeting industrial procurement and export requirements.
6. Can you customize product specifications or packaging?
Yes, we support customization of parameters such as purity, impurities, residual solvents, and heavy metals. We also offer various bulk packaging options, including 25kg bags, drums, and IBC tanks, suitable for industrial applications and transportation.
7. What shipping options do you support?
We support both FCL (Full Container Load) and LCL (Less than Container Load) shipments, and can flexibly arrange logistics solutions based on order size to meet bulk chemical export needs.
8. Do you provide technical or application support?
Yes, we provide basic application guidance and technical support based on industry experience to help customers optimize product usage.
9. How do you handle compliance and export regulations?
We are familiar with international trade and export regulations, ensuring all products comply with relevant requirements. We also provide complete documentation to support smooth customs clearance and global delivery.
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